MAUDE Adverse Event Report: Inogen Inc. Inogen One G4 Bluetooth Portable Oxygen Concentrator

Model Number	IO-400
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	08/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's unit had a replace columns message and then stopped working.As a result, the patient had difficulty breathing, but they were able to make it back home to their stationary concentrator without further intervention.Troubleshooting did not resolve the issue and replacement columns were sent to the patient.The patient received the replacement columns and were able to resume their therapy with the unit.While the issue is with the columns, the patient's unit will be the reported device for this report.
Additional Manufacturer Narrative
B3 date of event is estimated.Columns are a disposable accessory and the old ones will not be returning.

• Brand Name: Inogen One G4 Bluetooth Portable Oxygen Concentrator
• Common Device Name: Inogen One G4 Bluetooth Portable Oxygen Concentrator
• Manufacturer (Section D): Inogen Inc.; 600 shiloh rd; plano TX 75074
• Manufacturer (Section G): Inogen Inc.; 600 shiloh rd; plano TX 75074
• Manufacturer Contact: greg porter ; 600 shiloh rd; plano, TX 75074
• MDR Report Key: 50873002
• Report Number: 3004672275-2026-00307
• Device Sequence Number: 9314702
• Product Code: CAW
• UDI-Device Identifier: 00817131020179
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K032818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: IO-400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/04/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown